Market Opportunity - Approximately 16.5 million Americans suffer from rosacea, with only 2-3 million currently receiving treatment, indicating a significant market opportunity[19][39]. - The total addressable market for rosacea treatments is expanding, with a significant portion of patients not currently receiving adequate care[41]. - The U.S. population of approximately 345 million includes around 242 million lives covered by commercial, government, and Medicare plans, highlighting a significant market opportunity[96]. Product Efficacy and Safety - Emrosi received FDA approval in November 2024, demonstrating superior efficacy compared to both placebo and the market-leading oral rosacea treatment, Oracea[10]. - Emrosi's clinical trials showed a treatment success rate of 28.2% at week 16, significantly outperforming Oracea and placebo with a p-value of <0.001[30][31]. - Emrosi's safety profile is comparable to placebo, with most treatment-related adverse events reported as mild or moderate[32]. - Emrosi is positioned as the best-in-class oral therapy for inflammatory lesions of rosacea, with a unique mix of patient benefits including head-to-head superiority over Oracea demonstrated in two Phase 3 trials[74]. Market Demand and Sales Strategy - The oral rosacea market is projected to have over 712,000 prescriptions filled in 2024, highlighting the growing demand for effective treatments[45]. - Journey Medical has established a dedicated dermatology sales force to capitalize on the commercial potential of Emrosi[10]. - Journey Medical's sales force can cover 83% of Oral Rosacea prescriptions at launch, with 547,349 total prescriptions expected in 2024[51]. - The market is highly concentrated, with 3,127 writers responsible for 80% of prescriptions, averaging 48 prescriptions per writer[53]. - 74% of surveyed high rosacea prescribers believe Emrosi is "very likely" to be prescribed, indicating strong market interest[67]. Launch and Marketing Plans - Emrosi's launch is scheduled for April 2025, following FDA approval and payer notifications[99]. - Journey Medical aims to establish Emrosi as the oral standard of care through targeted HCP digital advertising and educational programs[65][90]. - The company plans to exhibit at the AAD 2025 conference and utilize KOLs to promote Emrosi among healthcare providers[89]. Financial and Research Initiatives - The company plans to pursue out-licensing opportunities to generate additional cash flow and future revenue streams[10]. - Journey Medical is committed to ongoing research, with multiple manuscript submissions planned for leading peer-reviewed journals covering safety, efficacy, and quality of life improvements[35]. Pricing Sensitivity - HCPs are sensitive to patient out-of-pocket costs above $50 per month, which may impact prescription rates[70].
Journey Medical (DERM) - 2024 Q4 - Annual Results